Sitagliptin in Combination With Beidougen Capsule for Type 2 Diabetes

NCT ID: NCT05667220

Last Updated: 2023-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-12-31

Brief Summary

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The study was an interventional non-randomized controlled study and was divided into a Sitagliptin monotherapy (100 mg Qd) group and a Sitagliptin (100mg Qd)+Beidougen capsule (60mg Tid) combination treatment group for one week.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sitagliptin monotherapy group (Group A)

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

Sitagliptin monotherapy group (Group A): 20 eligible patients were planned to be included and given Sitagliptin 100 mg Qd orally; the treatment period was 1 week.

Sitagliptin combined with Beidougen capsule treatment group (Group B)

Group Type EXPERIMENTAL

Sitagliptin combined with Beidougen capsule

Intervention Type DRUG

Sitagliptin combined with Beidougen capsule treatment group (Group B): 20 eligible patients were planned to be included and given sitagliptin 100mg Qd orally combined with Beidougen capsule 60mg Tid orally. The treatment period was 1 week.

Interventions

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Sitagliptin

Sitagliptin monotherapy group (Group A): 20 eligible patients were planned to be included and given Sitagliptin 100 mg Qd orally; the treatment period was 1 week.

Intervention Type DRUG

Sitagliptin combined with Beidougen capsule

Sitagliptin combined with Beidougen capsule treatment group (Group B): 20 eligible patients were planned to be included and given sitagliptin 100mg Qd orally combined with Beidougen capsule 60mg Tid orally. The treatment period was 1 week.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18-65 years with a first diagnosis of type 2 diabetes
* Diagnostic criteria HbA1c ≥ 7%

Exclusion Criteria

* The positive of diabetes antibodies
* Anti-diabetic drugs therapy before participation
* Pancreatitis
* Coronary artery disease
* Liver function impairment
* Renal function impairment
* History of intestinal surgery
* Chronic hypoxic diseases (emphysema and cor pulmonale)
* Infectious disease
* Hematological disease
* Systemic inflammatory disease
* Cancer
* Pregnant
* Ingesting agents known to influence glucose or lipid metabolism
* Any antibiotics or probiotics in the past three months prior to the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guang Wang

Beijing Chao Yang Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guang Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Locations

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Beijing Chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jia Liu, MD

Role: CONTACT

010-85231710

Yan Duan, MD

Role: CONTACT

010-85231711

Facility Contacts

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Jia Liu, MD

Role: primary

010-8523161710

Other Identifiers

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2022-Sitagliptin-Beidougen

Identifier Type: -

Identifier Source: org_study_id

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